JP2023507171A - Systems and methods for modular endoscopy - Google Patents

Abstract

An articulating flexible endoscope is provided. The endoscope includes a distal tip portion steerable via a drive mechanism and a bending section connected to the distal tip portion at a first end and connected to the shaft portion at a transition interface for bending. A flexing section, the section being articulated by one or more pull wires, to reduce at least a portion of the articulation forces exerted on the flexing section by the one or more pull wires, thereby improving the stability of the shaft portion. and a shaft portion including one or more load transfer tubes of , the one or more load transfer tubes being rigidly secured to the transition interface and having a length greater than the length of the shaft portion.

Description

reference
[0001] This application is subject to U.S. Provisional Patent Application No. 62/950,740, filed Dec. 19, 2019, and U.S. Provisional Patent Application No. 63/091, filed Oct. 13, 2020. , 268, each of which is incorporated herein by reference.

Background of the invention
[0002] Endoscopy procedures use an endoscope to examine the interior of hollow organs or body cavities. Unlike many other medical imaging techniques, endoscopes are inserted directly into organs. Flexible endoscopes that can provide intuitive steering and control are useful in diagnosing and treating diseases accessible through any natural orifice in the body. Depending on the clinical indication, endoscopes may be designated as bronchoscopes, ureteroscopes, colonoscopes, gastroscopes, otorhinolaryngoscopes, and various others. For example, flexible endoscopy is used to examine and treat disorders of the gastrointestinal (GI) tract without the need to create an opening in the patient's body. An endoscope is introduced into the upper or lower gastrointestinal tract through the mouth or anus, respectively. A miniature camera at the distal end captures images of the gut wall that help clinicians diagnose gastrointestinal disease. Simple surgical procedures (such as polypectomy and biopsy) can be performed by introducing a flexible tool through the working channel with the distal end reaching the site of interest.

[0003] Conventionally, endoscopes are made to be reusable and may require thorough cleaning, disinfection and/or sterilization after each procedure. In most cases cleaning, disinfection and sterilization can be positive processes to kill germs and/or bacteria. Such procedures can also be harsh on the endoscope itself. Therefore, the design of such reusable endoscopes can often be complicated, especially to ensure that the endoscope can withstand such harsh cleaning, disinfection and sterilization protocols. have a nature. Periodic maintenance and repair of such reusable endoscopes is often required.

[0004] Low cost, disposable medical devices designated for single use have become a popular alternative to instruments that are difficult to clean properly. Single-use, disposable devices may be packaged in sterile packaging to avoid the risk of pathogenic cross-contamination of diseases such as HIV, hepatitis, and other pathogens. Hospitals generally welcome the convenience of single-use, disposable products because they no longer have to worry about product age, overuse, breakage, failure, or sterilization. Conventional endoscopes often include a handle that an operator uses to manipulate the endoscope. For single-use endoscopes, the handle typically includes a camera and expensive electronics and mechanical structures to transmit images and allow the user to operate the endoscope through a user interface. and are enclosed in the proximal end. This can result in high cost handles for single-use endoscopes.

SUMMARY OF THE INVENTION
[0005] A need is recognized herein for an endoscope that allows surgical or diagnostic operations to be performed with improved outcomes and cost efficiency. Also recognized herein are devices and systems, including endoscopes, that can be disposable and do not require extensive cleaning procedures. The present disclosure finds diagnostic and therapeutic applications in various applications such as bronchoscopy, urology, gynecology, arthroscopy, orthopedics, otorhinolaryngology, gastrointestinal endoscopy, neurosurgery, and various others. To provide a low-cost, single-use, articulatable endoscope for. Provided endoscopic systems can be used in a variety of minimally invasive surgical, therapeutic or diagnostic procedures, including, but not limited to, esophageal, esophageal, esophageal, esophageal, esophageal, esophageal, and endoscopic systems. Other anatomy of the patient's body such as the digestive system, including the liver, stomach, colon, urinary tract, or the respiratory system, including but not limited to the bronchi, lungs, and various others. Note that it can be used in

[0006] The various components of the provided modular endoscopic components and devices are suitable for various minimally invasive surgical, therapeutic or therapeutic procedures involving various types of tissue, including heart, bladder and lung tissue. In diagnostic procedures, the gastrointestinal system, including but not limited to esophagus, liver, stomach, colon, urinary tract, or including but not limited to bronchi, lungs, and various others , may be used in other anatomical regions of the patient's body, such as the respiratory system.

[0007] In one aspect, an articulating flexible endoscope is provided. The articulating flexible endoscope includes a distal tip portion steerable via a drive mechanism and a bending section connected to the distal tip portion at a first end and to a shaft portion at a transition interface. wherein the flexion section is articulated by one or more pull wires, and one or more loads for accommodating the one or more pull wires and thereby improving the stability of the shaft portion and a shaft portion containing the transmission tube.

[0008] In some embodiments, the distal tip portion includes structure for receiving an imaging device, a position sensor, and an illumination device. In some embodiments, each of the one or more pull wires is disposed within a respective load transfer tube lumen of the one or more load transfer tubes. In some embodiments, the bending section bends in more than one direction with one or more pull wires. In some embodiments, one or more load transfer tubes are rigidly secured to the transition interface and have a length greater than the length of the shaft portion. In some embodiments, one or more load transfer tubes have a non-linear configuration. In some embodiments, the one or more load transfer tubes have a helical configuration.

[0009] In some embodiments, the shaft portion includes a tube with an integrally formed structure for varying the stiffness of the shaft portion. In some embodiments, the articulating flexible endoscope further includes a deformable working channel. In some embodiments, the flexible articulating endoscope further includes a handle portion that includes one or more electronic components located at the distal tip portion to process the image data. It includes one or more components configured to provide power to the element or establish communication with an external device. Optionally, the handle portion includes an interface configured to couple the handle portion to the instrument drive mechanism. In some examples, the interface is an electrical interface and a mechanical interface. Optionally, the handle portion includes a mechanical control module for interfacing with an irrigation or aspiration system.

[0010] In another aspect, a disposable endoscope is provided. A disposable endoscope includes a distal tip portion including an imaging device, a position sensor, and an illumination device, and a bend connected to the distal tip portion at a first end and to a shaft portion at a second end. a section, the flexion section being articulated by one or more pull wires; and a shaft portion containing the load transfer tube.

[0011] In some embodiments, the distal tip portion includes structure for receiving an imaging device, a position sensor, and an illumination device. In some embodiments, the imaging device, position sensor, and lighting device are arranged in a compact configuration. In some embodiments, the one or more load transfer tubes have a length that is greater than the length of the shaft portion.

[0012] In some embodiments, each of the one or more pull wires is disposed within a respective load transfer tube lumen of the one or more load transfer tubes. In some embodiments, one or more pull wires are movable relative to one or more load transfer tubes. In some embodiments, the bending section bends in more than one direction with one or more pull wires. In some embodiments, one or more load transfer tubes have a non-linear configuration. In some embodiments, the one or more load transfer tubes have a helical configuration.

[0013] In some embodiments, the shaft portion includes a tube with an integrally formed structure for varying the stiffness of the shaft portion. In some embodiments, the single-use endoscope further includes a deformable working channel. In some embodiments, the single-use endoscope further includes a handle portion, the handle portion to process image data, to provide power to the imaging device, the position sensor, and the lighting device, or the external It includes one or more components configured to establish communication with a device. Optionally, the handle portion includes an interface configured to couple the handle portion to the instrument drive mechanism. In some examples, the interface includes an electrical interface and a mechanical interface. In some examples, the mechanical interface is configured to removably couple the handle portion to the instrument drive mechanism.

[0014] Additional aspects and advantages of the present disclosure will become readily apparent to those skilled in the art from the following detailed description, wherein only exemplary embodiments of the present disclosure are shown and described. As will be realized, the disclosure is capable of other and different embodiments, and its several details are capable of modifications in various obvious respects, all without departing from the disclosure. Accordingly, the drawings and description are to be considered illustrative in nature and not restrictive.

Incorporation by Reference
[0015] All publications, patents and patent applications referred to in this specification are to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference. , incorporated herein by reference. To the extent any publications and patents or patent applications incorporated by reference conflict with the disclosure contained herein, the present specification is intended to supersede and/or take precedence over such conflicting material. It is

Brief description of the drawing
[0016] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention may be had by following the detailed description and accompanying drawings (also referred to herein as "figures") which set forth exemplary embodiments in which the principles of the invention are employed. )” and “FIG.”).

[0017] Fig. 2 illustrates an example of a flexible endoscope, according to some embodiments of the present disclosure; [0018] Fig. 2 illustrates an example endoscope with an articulation force transmission mechanism, according to some embodiments of the present invention; [0019] Fig. 4 illustrates an example of one or more pull wires assembled to one or more load transfer tubes in a flex section; [0019] Fig. 4 illustrates an example of one or more pull wires assembled to one or more load transfer tubes in a flex section; [0020] Fig. 4 illustrates an example load transfer tube terminated in a distal shaft region and a proximal shaft region. [0021] Fig. 5 illustrates an example of a load transfer tube terminated in a distal shaft region and a proximal shaft region. [0022] Fig. 2 shows an example of an existing steerable catheter construction. [0023] Fig. 4 shows an example of an insertion shaft design. [0024] Fig. 2 illustrates an example of a robotic bronchoscope, according to some embodiments of the present invention; [0025] FIG. 4 illustrates an example of an instrument drive mechanism that provides a mechanical interface to the handle portion of a robotic bronchoscope, according to some embodiments of the present invention; [0026] Fig. 2 illustrates an exemplary handle portion of a robotic bronchoscope, according to some embodiments of the present invention; [0027] Fig. 2 illustrates an exemplary steerable catheter, according to some embodiments of the present invention; [0028] Fig. 4 depicts an exemplary distal portion of a catheter with integrated imaging and lighting devices. [0029] Fig. 6 illustrates an example of a compact configuration of multiple electronic elements located in the distal portion of a catheter, according to some embodiments of the present invention; [0030] FIG. 7 illustrates an example of a conventional configuration of pull wires attached to a control ring structure and the novel configuration of the present disclosure; [0031] Fig. 2 illustrates various configurations of pull wires for a robotic catheter system, according to some embodiments of the present invention; [0032] Fig. 10 illustrates an example of a guidewire with an expandable tip, according to some embodiments of the present invention; [0033] Fig. 10 illustrates an example of an endoscope tip design.

Detailed description of the invention
[0034] While various embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, modifications, and substitutions may occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be used.

[0035] The embodiments disclosed herein can be combined in one or more of many ways to provide improved diagnosis and treatment to patients. The disclosed embodiments combine with existing methods and devices to provide improved treatments, e.g., in combination with known methods of pulmonary diagnostics, surgery, and other tissue and organ surgery. be able to. Any one or more of the structures and steps described herein can be combined with any one or more of the additional structures and steps of the methods and apparatus described herein, and the drawings and supplementary It should be appreciated that the text provides explanations according to embodiments.

[0036] While the exemplary embodiments are primarily directed to bronchoscopy devices or systems, those skilled in the art will appreciate that this is not intended to be limiting. Also, the devices described herein may be used in various anatomical regions of a patient's body for other therapeutic or diagnostic procedures. Provided devices or systems are used for urology, gynecology, rhinology, otolology, laryngoscopy using endoscopes, combined devices including endoscopes and instruments, endoscopes with localization capabilities. , can be used in gastroenterology. Those skilled in the art will appreciate that this is not intended to be limiting. The devices described herein can also be used for neuroendoscopes, encephaloscopes, ophthalmoscopes, otoscopes, rhinoscopes, laryngoscopes, gastroscopes, esophagoscopes, bronchoscopes, in combination with various tools or instruments. Thoracoscope, pleuroscope, angioscope, mediastinoscope, nephroscope, gastroscope, duodenoscope, choledoscope, cholangioscope, laparoscope, amnioscope, ureteroscope, hysteroscope, cystoscope, rectoscope, colonoscope , arthroscopes, salivary endoscopy, orthopedic endoscopy, and others for other therapeutic or diagnostic procedures such as brain, heart, lung, intestine, eye, skin, kidney, liver, pancreas, Stomach, uterus, ovary, testis, bladder, ear, nose, mouth, bone marrow, adipose tissue, muscle, glandular and mucosal tissue, spinal cord and nerve tissue, soft tissue such as cartilage, hard living tissue such as tooth, bone, and sinus , ureters, colon, esophagus, pulmonary passages, vessels and cavities and passageways such as the pharynx, and various others.

[0037] The systems and devices herein can be combined in one or more of many ways to provide improved diagnosis and treatment to patients. Embodiments provided herein use existing methods to provide improved treatments, for example, in combination with known methods of pulmonary diagnostics, surgery, and other tissue and organ surgery. Can be combined with methods and devices. Any one or more of the structures and steps described herein can be combined with any one or more of the additional structures and steps of the methods and apparatus described herein, and the drawings and supplementary It should be appreciated that the text provides explanations according to embodiments.

[0038] Whenever the terms "at least," "greater than," or "greater than" precede the first numerical value in a series of two or more numerical values, "at least," "greater than," or " The term "greater than or equal to" applies to each number in that series of numbers. For example, 1, 2, or 3 or more is equivalent to 1 or more, 2 or more, or 3 or more.

[0039] Whenever the terms "not greater than," "less than," or "less than or equal to" precede the first number in a series of two or more numbers, "not greater than," "less than," or "less than or equal to" The term applies to each number in that series of numbers. For example, 3, 2, or 1 or less is equivalent to 3 or less, 2 or less, or 1 or less.

[0040] As used herein, the terms distal and proximal may generally refer to positions relative to the device and may be as opposed to anatomical reference. For example, the distal position of the main shaft or catheter may correspond to the proximal position of the patient's elongate member, and the proximal position of the main sheath or catheter may correspond to the distal position of the patient's elongate member.

modular flexible endoscope
[0041] In one aspect of the present invention, a flexible endoscope with improved outcomes at reduced cost is provided. FIG. 1 illustrates an example flexible endoscope 100, according to some embodiments of the present disclosure. As shown in FIG. 1, flexible endoscope 100 may include a handle portion 109 and a flexible elongate member that is inserted inside a subject. In some embodiments, a flexible elongate member can include a shaft (eg, insertion shaft 101), a steerable tip (eg, tip 105), and a steerable section (bending section 103). . Endoscope 100 is sometimes referred to as a steerable catheter assembly, as described elsewhere herein. Optionally, endoscope 100 may be a single-use robotic endoscope. Optionally, the entire catheter assembly can be disposable. Optionally, at least a portion of the catheter assembly may be disposable. Optionally, the entire endoscope may be removed from the instrument drive mechanism and discarded. In some embodiments, the endoscope can have varying levels of stiffness along the shaft to improve functional movement.

[0042] Endoscope or steerable catheter assembly 100 is configured to process image data, provide power, or establish communication with other external devices. It may include a handle portion 109 that may include multiple components. For example, the handle portion may include circuitry and communication elements that allow electrical communication between the steerable catheter assembly 100 and an instrument drive mechanism (not shown) and any other external system or device. In another example, the handle portion 109 may include circuitry such as a power supply for providing power to the endoscope's electronics (eg, camera, electromagnetic sensor and LED lights).

[0043] One or more of the components located in the handle reduces costs by dedicating expensive and complex components to the robotic support system, hand-held controller or instrument drive mechanism, thereby reducing costs and reducing the cost of single-use endoscopes. can be optimized such that the design of is simplified. Optionally, the handle portion can receive image/video data and/or sensor data by the communication module of the instrument drive, so that the image/video data and/or sensor data can be transmitted to other external devices/systems. It may be in electrical communication with an instrument drive mechanism (eg, FIG. 8, instrument drive mechanism 820) via an electrical interface (eg, printed circuit board). In some cases, an electrical interface may establish electrical communication without cables or wires. For example, an interface may include pins soldered to an electronic substrate such as a printed circuit board (PCB). For example, a receptacle connector (eg, female connector) is provided on the instrument drive mechanism as a mating interface. This may advantageously allow the endoscope to be quickly plugged into an instrument drive mechanism or robotic support without the use of extra cables. Such type of electrical interface can also serve as a mechanical interface such that both mechanical and electrical coupling is established when the handle portion is plugged into the instrument drive mechanism. Alternatively or additionally, the instrument drive mechanism may provide only a mechanical interface. The handle portion electrically communicates with a modular wireless communication device or any other user device (e.g., portable/handheld device or controller) to transmit sensor data and/or receive control signals. obtain.

[0044] Optionally, handle portion 109 may include one or more mechanical control modules such as luer 111 for interfacing with an irrigation/suction system. Optionally, the handle portion may include a lever/knob for articulation control. Alternatively, articulation control may be located in a separate controller attached to the handle portion via the instrument drive mechanism.

[0045] The endoscope may be attached to a robotic support system or a handheld controller via an instrument drive mechanism. The instrument drive mechanism may be provided by any suitable controller device (eg, handheld controller), which may or may not include a robotic system. An instrument drive mechanism may provide a mechanical and electrical interface to steerable catheter assembly 100 . A mechanical interface may allow the steerable catheter assembly 100 to be removably coupled to an instrument drive mechanism. For example, the handle portion of the steerable catheter assembly can be attached to the instrument drive mechanism via quick attachment/detachment means such as magnets, spring-loaded levels, and the like. Optionally, the steerable catheter assembly can be manually coupled to or removed from the instrument drive mechanism without the use of tools. Details of the instrument drive mechanism are described later in this specification.

[0046] In the illustrated example, the distal tip of the catheter or endoscope shaft is articulated/flexed in two or more degrees of freedom to provide a desired camera view or to control the orientation of the endoscope. configured to be As shown in the example, an imaging device (eg, camera), position sensor (eg, electromagnetic sensor) 107 is located at the distal end 105 of the catheter or endoscope shaft. For example, the camera's line of sight can be controlled by controlling the articulation of flexion section 103 . In some examples, the angle of the camera may be adjustable so that the line of sight can be adjusted without or in addition to articulating the distal tip of the catheter or endoscope shaft. For example, the camera can be oriented at an angle (eg, tilt) to the axial direction of the tip of the endoscope using optimal components.

[0047] Distal tip 105 allows positioning of sensors such as electromagnetic (EM) sensors, imaging devices (e.g., cameras) and other electronic components (e.g., LED light sources) embedded in the distal tip. It can be a rigid component that

[0048] In real-time electromagnetic tracking, an EM sensor consisting of one or more sensor coils implanted in a medical instrument (e.g., the tip of an endoscopic tool) in one or more positions and orientations is used to track the patient. measuring the variations in the electromagnetic field produced by one or more electrostatic field generators positioned at positions proximate to . Positional information detected by the EM sensor is stored as EM data. An electromagnetic field generator (or transmitter) can be placed near the patient to produce a low-strength magnetic field that can be detected by the implanted sensor. The magnetic field induces a weak current in the sensor coil of the EM sensor, and this current can be analyzed to determine the distance and angle between the EM sensor and the electromagnetic field generator. For example, the electromagnetic field generator may be positioned near the patient's torso during treatment to locate the position of the EM sensor in 3D space, or may locate the position and orientation of the EM sensor in 5D or 6D space. . This may provide visual guidance to the operator when driving the bronchoscope toward the target site. Details of the chip design and the multiple components embedded in the chip are described later in this specification.

[0049] An endoscope may have a unique design for the shaft component. Optionally, an endoscope insertion shaft may consist of a single tube incorporating a series of cuts (eg, undulations, slits) along the length of the insertion shaft to provide enhanced flexibility and desired stiffness. Details of the shaft design are described later in this specification.

[0050] Flexion section 103 may be designed to allow flexion in two or more degrees of freedom (eg, articulation). Greater degrees of flexion (or other articulation parameters of clinical indication) such as 180 and 270 degrees can be achieved by the unique construction of the flexion section. Optionally, the flexion section can be manufactured separately as a modular component and assembled to the insertion shaft. In some cases, the flexion section may also incorporate minimal functionality, thereby reducing cost and increasing reliability. For example, the bending section may incorporate a cut pattern that beneficially provides a greater degree of tube flexure to achieve the desired tip displacement relative to the insertion shaft.

[0051] In some embodiments, the bending section or endoscope has an articulation force transmission mechanism to ensure that the endoscope is stable and provides intuitive responsiveness of the bending section. can include FIG. 2 illustrates an example endoscope with an articulation force transmission mechanism 201, according to some embodiments of the present invention. The articulation force transmission mechanism 201 may include multiple load transmission tubes located within the bore of the insertion shaft/tube. Optionally, at least 1, 2, 3, 4, 5, or more loads to reduce axial compression/extension (strain) of insertion tube 203 during articulation of the flexion section A transmission tube may be included. The load transfer tube transfers at least a portion of the articulation load on the flexion section and/or shaft (e.g., via an actuator or motor that drives one or more articulated pull wires) back to the handle. obtain.

[0052] The shaft portion may include one or more load transfer tubes for accommodating one or more pull wires. The load transfer tube counteracts articulation loads and provides increased stability of the insertion shaft. A plurality of load transfer tubes 201 reside within the shaft tube lumen (ie, tube bore) and may be configured to transfer articulation reaction forces from the flexion section to the handle portion. The load transfer tube is configured to transfer articulation reaction forces of the flexion section back to the handle portion, thereby reducing articulation forces on the insertion shaft tube. Such a design may beneficially prevent these articulation forces from being resolved through the insertion shaft tube, thereby providing a stable shaft. The transmission modalities described herein may ensure that the insertion shaft tube experiences minimal axial compression or extension forces, thereby remaining stable during articulation of the flexion section.

[0053] In a preferred embodiment of the load transfer mechanism, the plurality of load transfer tubes 201 may be longer than the length of the insertion shaft tube 203. The length of the plurality of load transfer tubes 201 is such that the length of the load transfer tubes is still greater than the length of the insertion shaft tube 203 when the load transfer tubes are in an axially compressed state, thereby can be determined such that the transmission of loads through is prevented. For example, the length of the load transfer tube may be at least 0.01%, 0.1%, 0.2%, 0.3%, 1%, 5%, 10% longer than the length of the insertion shaft. The length of the load transfer tube may be determined based at least in part on the inner diameter dimension of the shaft. For example, the load transfer tube may have a helical configuration that provides sufficient stiffness to support/transfer the load.

[0054] The load transfer tube may be sized and configured to accommodate displacement within the shaft tube. For example, when the insertion shaft tube 203 bends, such as by following tortuous anatomy, the insertion shaft tube may cause displacement of components housed within the bore of the insertion shaft tube. In this case, the extra length of the load transfer tube can beneficially improve the stability of the shaft while accommodating displacement within the bore of the insertion shaft tube. Compared to existing technology that may utilize coil pipes and service loops within the handle portion, the modular design and assembly of the load transfer tube can beneficially reduce costs without compromising shaft performance. Compared to other existing techniques where pull wires are incorporated into the shaft (shown in FIG. 6), the provided load transfer mechanism beneficially transfers load from the flex section to the handle without compressing the shaft, Thereby, the stability of the shaft can be improved.

[0055] A plurality of load transfer tubes may be fixedly secured to the proximal end 207 and the distal end 205 of the insertion shaft tube 203. As shown in FIG. As explained above, since the load transfer tube is longer than the length of the insertion shaft tube, the load transfer tube has a non-linear/non-linear configuration in the bore of the insertion shaft tube that provides flexibility to accommodate displacement caused by flexing. can have in For example, one or more of the load transfer tubes may be used in an endoscope that takes into account the shape change of the length of the shaft as the endoscope follows a tortuous shape while indwelling within the anatomy. can have a non-linear (eg, helical) configuration that allows movement within the main lumen of the . Such a load transfer mechanism may beneficially act as a natural spring to counteract motion from the outer insertion shaft.

[0056] In some embodiments, one or more load transfer tubes may surround one or more pull wires. Articulation of the endoscope may be controlled by applying force to the distal end of the endoscope via one or more pull wires. One or more pull wires may be attached to the distal end of the endoscope. In the case of multiple pull wires, pulling one wire at a time may change the orientation of the distal tip to tilt up, down, left, right, or in any direction required. Optionally, a pull wire may be fixedly secured to the distal tip of the endoscope, extend through the bend section, and enter the handle, where the pull wire is attached to a drive component (e.g., a pulley). ). This handle pulley can interact with an output shaft from the robotic system.

[0057] In some embodiments, the one or more pull wires may be located within or extend through the interior of the one or more load transfer tubes. 3A and 3B show an example of one or more pull wires 305 assembled to load transfer tubes 307 in flex section 301. FIG. As shown in FIG. 3A, flexure section 301 may be constructed from a stainless steel ribbon. The flexion section may be formed of other suitable structures or materials to achieve a predetermined bending stiffness while maintaining desired axial and torsional stiffness for small articulation forces. For example, the flex section can include a braided structure for torsional stability. In the illustrated example, a plurality of pull wires 305 may extend through or be disposed within the lumen and bend section of load transfer tube 307, which terminates at the distal end of the endoscope.

[0058] For example, a drive mechanism (eg, actuator, motor) may be engaged with the pull wire to articulate the flexion section. The one or more load transfer tubes absorb at least a portion of the articulation load (e.g., compressive force) by, for example, placing one or more pull wires within each of the one or more load transfer tubes. from the flexure section back to the handle or motor. During articulation, relative motion can occur between the pull wires and corresponding load-carrying tubes. The one or more load transmission tubes transmit at least a portion of the articulation load on the flexure section and/or shaft back to the handle (eg, the motor driving the one or more articulation pull wires). obtain. This may beneficially reduce at least a portion of the articulation forces on the flexion section and/or the insertion shaft, thereby improving the stability of the insertion shaft.

[0059] The endoscope may include a bending section transition 303 located at the joint boundary between the bending section and the shaft. Flexion section transition 303 may include structure that may allow for efficient and convenient assembly of the endoscope. For example, the flexion section transition 303 may include mechanical components such as snaps/clips to secure the load transfer tube (eg, hypotube) to the cutout feature of the insertion shaft. FIG. 3B shows another example of flexion section transition 309 . In the illustrated example, the load transfer tube may be secured to the interface between the insertion shaft and the flexion section by welding to the transition ring structure of flexion section transition 309 . This may beneficially reduce abrupt stiffness changes between the shaft portion and the flex section, thereby preventing kinking.

[0060] FIG. 4 shows an example of a load transfer tube 401 terminated in a distal shaft region 403 and a proximal shaft region 405. As shown in FIG. As explained above, the load transfer tube may have a non-linear/non-linear configuration within the bore of the insertion tube to provide flexibility to accommodate displacement caused by flexion. The load transfer mechanism may include one or more load transfer tubes, as shown in the examples. Such a load transfer mechanism may beneficially act as a natural spring to dampen motion from the outer insertion shaft without requiring additional service loops in the handle portion. In the illustrated example, the end portion of the load transfer tube may be connected (eg, welded) and secured to the flexure section transition 407 . Flexion section transition 407 may include coupling structure 409 (eg, snap structure) for easy assembly to the insertion shaft.

[0061] Optionally, one or more of the load transfer tubes may be constructed of materials such as metal tubing or metal wound coiled pipe. The load transfer tube geometry and/or materials may be selected/determined to provide the desired axial and bending stiffness. For example, materials can be metallic materials such as stainless steel or nitinol, hard polymers such as PEEK, glass or carbon filled PEEK, Ultem, polysulfone, and other suitable materials. Optionally, one or more of the load transfer tubes have an inner diameter that is greater than the outer diameter of the pullwires to allow relative movement (e.g., translational and/or rotational movement) between the load transfer tubes and the pullwires. obtain. The wall thickness of the one or more load transfer tubes may be determined based on the load transfer function required to transfer the articulation load of the flexion section.

[0062] Figure 5 shows an example of a load transfer tube 501 terminated in a distal shaft region 503 and a proximal shaft region. The load transfer tube 501 may be located within the lumen of the insertion shaft (not shown) and outside the working channel 505, as described elsewhere herein.

[0063] FIG. 6 illustrates an example of an existing steerable catheter structure 600. As shown in FIG. In existing catheter designs without load carrying tubes, one or more pull wires 609 typically extend through conduits 607 built into the walls of insertion shaft 605 and bending section 603 . The catheter shaft can have a central bore/lumen 611 coaxial with the neutral axis. As shown in cross-section, the wall of the shaft or the wall of the bend section may have built-in structures (eg, lumens, conduits) for passage of pull wires. In such cases, the shaft may carry articulating loads that can result in an unstable shaft.

[0064] Figure 7 shows an example of an insertion shaft design. As explained above, the insertion shaft of an endoscope may be constructed from a single tube with integrally formed structures for varying the stiffness of the shaft portion. For example, the tube may have a series of cuts (or undulations, slits, etc.) formed along its length. The cuts in the tube can have varying contours/patterns 701, 703 and densities along the length to create varying bending stiffness from distal to proximal regions. This may beneficially allow the bending stiffness parameter to be controlled by controlling the cut in the insertion shaft.

A low-cost, single-use robotic bronchoscope
[0065] In another aspect of the invention, a single use robotic bronchoscope is provided. The robotic bronchoscope can be the same as the steerable catheter assembly as described elsewhere herein. Conventional endoscopes can be complex in design and are usually designed to be reused after procedures, which require extensive cleaning, disinfection or sterilization after each procedure. . Existing endoscopes are often designed with complex structures so that the endoscope can withstand cleaning, disinfection and sterilization processes. The provided robotic bronchoscope can be a single-use endoscope that can beneficially reduce cross-contamination and infection between patients. In some cases, the robotic bronchoscope is delivered to the physician in pre-sterilized packaging and is intended to be discarded after a single use.

[0066] Figures 8-10 illustrate an example of a robotic bronchoscope, according to some embodiments of the present invention. As shown in FIG. 8, robotic bronchoscope 820 may include handle portion 813 and flexible elongate member 811 . In some embodiments, flexible elongate member 811 can include a shaft, a steerable tip, and a steerable section. The robotic bronchoscope 820 can be the same as the steerable catheter assembly as described in FIG. The robotic bronchoscope can be a single-use robotic endoscope. Optionally, the catheter alone may be disposable. Optionally, at least a portion of the catheter can be disposable. Optionally, the entire robotic bronchoscope can be removed from the instrument drive and discarded. Bronchoscopes can have varying levels of stiffness along the shaft of the bronchoscope to improve functional movement.

[0067] The robotic bronchoscope can be removably coupled to the instrument drive mechanism 820. FIG. The instrument drive mechanism 820 may be attached to an arm of a robotic support system or to any actuating support system as described elsewhere herein. An instrument drive mechanism may provide a mechanical and electrical interface to robotic bronchoscope 820 . A mechanical interface may allow the robotic bronchoscope 820 to be removably coupled to an instrument drive mechanism. For example, the handle portion of a robotic bronchoscope can be attached to the instrument drive mechanism via quick attachment/detachment means, such as magnets and spring-loaded levels. Optionally, the robotic bronchoscope can be manually coupled to or detached from the instrument drive mechanism without the use of tools.

[0068] Figure 9 shows an example of an instrument drive mechanism 920 that provides a mechanical interface to the handle portion 913 of a robotic bronchoscope. As shown in the example, the instrument drive mechanism 920 may include a set of motors that operate to rotationally drive a set of pull wires of the catheter. The handle portion 913 of the catheter assembly can be attached to an instrument drive mechanism such that the pulley assembly of the handle portion 913 is driven by a set of motors. The number of pulleys may vary depending on the pull wire configuration. Optionally, one, two, three, four, or more pull wires may be utilized to articulate the catheter.

[0069] The handle portion can be designed to make the robotic bronchoscope disposable at low cost. For example, conventional manual and robotic bronchoscopes may have cables at the proximal end of the bronchoscope handle. Cables often include illumination fibers, camera video cables, cables such as other sensor fibers or electromagnetic (EM) sensors, or shape sensing fibers. Such complex cables can add cost to the cost of the bronchoscope. The provided robotic bronchoscope can have an optimized design to utilize simplified structures and components while preserving mechanical and electrical functionality. In some cases, the handle portion of the robotic bronchoscope may employ a cableless design while providing the mechanical/electrical interface to the catheter.

[0070] FIG. 10 illustrates an exemplary handle portion 1000 of a robotic bronchoscope, according to some embodiments of the present invention. Optionally, handle portion 1000 can be a housing or include components configured to process image data, provide power, or establish communications with other external devices. obtain. In some cases, communication may be wireless communication. For example, wireless communication may include Wi-Fi, radio communication, Bluetooth, IR communication, or other types of direct communication. Such wireless communication capabilities enable robotic bronchoscope functionality in a plug-and-play fashion and can be conveniently discarded after a single use. Optionally, the handle portion may include circuitry such as a power supply for powering electronics (eg, cameras and LED light sources) located within the robotic bronchoscope or catheter.

[0071] The handle portion may be designed in conjunction with the catheter to eliminate cables or fibers. For example, the catheter portion has a single working channel that allows instruments to pass through a robotic bronchoscope, as well as low-cost electronics such as chip-on-tip cameras, light-emitting diodes (LEDs). , and a design with the EM sensor optimally positioned depending on the mechanical structure of the catheter. This may allow simplification of the design of the handle portion. For example, by using LEDs for lighting, terminations in the handle portion can be based on electrical soldering or wire crimping only. For example, the handle portion may include a proximal substrate to which the camera cable, LED cable and EM sensor cable terminate, while the proximal substrate connects to the interface of the handle portion to establish an electrical connection to the instrument drive mechanism. . As explained above, the instrument drive mechanism is attached to the robotic arm (robot support system) and provides the mechanical and electrical interface to the handle portion. This may advantageously improve assembly and packaging efficiency and simplify manufacturing processes and costs. Optionally, the handle portion along with the catheter can be discarded after one use.

single use steerable catheter
[0072] Figure 11 illustrates an exemplary steerable catheter 1100, according to some embodiments of the present invention. In some embodiments, the catheter may have a substantially unitary design in which one or more components may be integral with the catheter, thereby improving the kinematic dynamic performance of the steerable catheter. simplifies the assembly and manufacturing process while preserving As shown in the example, a steerable catheter may include an elongate member 1101 or probing portion that approximates tissue and/or regions to be examined. Elongate member 1101 is sometimes referred to as a catheter. Catheter 1101 may include internal structures such as working channel 1103 that allow tools, such as those described elsewhere herein, to be passed through. Optionally, the working channel can have dimensions, such as a diameter of about 2 mm, for compatibility with standard tools.

[0073] Catheter 1101 may be constructed of a material suitable for the desired flexibility or bending stiffness. In some cases, the material of the catheter can be substantially flexible (e.g., capable of bending in various directions and orientations) as well as maintain structural support for internal structures (e.g., working channels). can be selected as For example, the catheter may be made of any suitable material such as Provista Copolymer, vinyl (such as polyvinyl chloride), nylon (such as Vestamide, Grilamid, etc.), polyurethane, polyethylene, polypropylene, polycarbonate, polyester, silicone elastomer, acetate, and the like. Can be made of material. Optionally, the material may be a polymeric material, a biocompatible polymeric material, and the catheter may be flexible enough to be advanced through paths of low curvature without causing pain to the subject. . Optionally, the catheter may include a sheath. The sheath does not have to be the same length as the catheter. The sheath may be shorter than the catheter to provide the desired support. Alternatively, the catheter may be a substantially single piece component.

[0074] Optionally, the distal portion or tip of the catheter can be substantially flexible so that it can be steered in one or more directions (eg, pitch, yaw). The catheter may include the same tip portion, bending section and insertion shaft as described in FIGS. 1-5. In some embodiments, the catheter can have a bending stiffness that varies along its longitudinal axis. For example, a catheter may include multiple segments having different bending stiffnesses (eg, flexible, semi-rigid, and rigid). Bending stiffness can be varied by choosing materials with different stiffness/rigidity, by varying the structure in different segments (e.g., cuts, patterns), by adding additional support components, or any combination of the above. obtain. In some cases, the proximal end of the catheter does not need to flex significantly, so the proximal portion of the catheter employs additional mechanical structures (e.g., additional layers of material) to achieve greater bending stiffness. can be reinforced by Such designs can provide support and stability to the catheter. Optionally, varying bending stiffness can be achieved by using different materials during extrusion of the catheter. The use of different materials during extrusion can advantageously provide different degrees of stiffness along the shaft of the catheter in the extrusion manufacturing process without further fastening or assembly of different materials.

[0075] The distal portion of the catheter may be steered by one or more pull wires 1105. FIG. The distal portion of the catheter can be made of any suitable material such as copolymers, polymers, metals or alloys so that it can be bent by the pull wires. In some embodiments, the proximal ends or portions of one or more pull wires 1105 are operably coupled to various mechanisms (eg, gears, pulleys, etc.) within the handle portion of the catheter assembly. obtain. The pull wire 1105 can be a metal wire, cable or wire, or can be a polymer wire, cable or wire. Pull wire 1105 can also be made of natural or organic materials or natural or organic fibers. Pull wire 1105 may be any type of suitable wire, cable or wire capable of supporting various types of loads without deformation, significant deformation or breakage. A distal end or portion of one or more of the pull wires 1105 may be fixedly secured to or integral with a distal portion of the catheter such that manipulation of the pull wires by the control unit results in at least A force or tension that can steer or articulate the distal portion (e.g., flexible section) (e.g., up, down, pitch, yaw, or any direction therebetween) is applied to the distal portion can join.

[0076] As explained above, the pull wires may be made of any suitable material, such as stainless steel (eg, SS316), metals, alloys, polymers, nylon, or biocompatible materials. A pull wire can be a wire, cable, or thin wire. In some embodiments, different pull wires may be made of different materials to vary the load bearing capabilities of the pull wires. In some embodiments, different sections of the pull wire may be made of different materials to vary stiffness and/or load bearing capacity along the pull. In some embodiments, pull wires may be utilized to transmit electrical signals. A pull wire may extend through the lumen of one or more load transfer tubes, as described elsewhere herein.

[0077] The catheter may have dimensions such that one or more electronic components may be integrated into the catheter. For example, the outer diameter of the distal tip can be about 4-4.4 millimeters (mm) and the diameter of the working channel is such that one or more electronic components can be embedded within the wall of the catheter. It can be about 2 mm. However, based on different applications, the outer diameter can be any range less than 4 mm or greater than 4.4 mm, and the diameter of the working channel can be any range depending on the dimensions of the tool or the specific application. Note that it can be a range.

[0078] The one or more electronic components may include imaging devices, lighting devices, or sensors. In some embodiments, the imaging device may be a video camera 1113. Imaging devices may include optical elements and image sensors for capturing image data. The image sensor may be configured to generate image data in response to wavelengths of light. Various image sensors can be used to capture image data, such as complementary metal-oxide-semiconductor (CMOS) or charge-coupled devices (CCD). The imaging device can be an inexpensive camera. Optionally, the image sensor may be provided on the circuit board. The circuit board can be an imaging printed circuit board (PCB). The PCB may contain multiple electronic elements for processing image signals. For example, circuitry for CCD sensors may include A/D converters and amplifiers for amplifying and converting analog signals provided by the CCD sensor. Optionally, the image sensor can be integrated with amplifiers and converters for converting analog signals to digital signals so that no circuit board is required. Optionally, the output of the image sensor or circuit board can be image data (digital signals), which can be further processed by the camera circuitry or processor of the camera. In some cases, the image sensor may include an array of optical sensors.

[0079] The illumination device may include one or more light sources 1111 positioned at the distal tip. Light sources may be light emitting diodes (LEDs), organic LEDs (OLEDs), quantum dots, or any other suitable light source. Optionally, the light source can be a miniature LED or dual-tone flash LED lighting for compact designs.

[0080] The imaging device and lighting device may be integrated into the catheter. For example, the distal portion of the catheter may include suitable structures that match at least the dimensions of the imaging device and illumination device. Imaging and lighting devices may be embedded in the catheter. FIG. 12 shows an exemplary distal portion of a catheter with integrated imaging and lighting devices. A camera may be located at the distal portion. The distal tip may have structure for receiving a camera, lighting device and/or position sensor. For example, a camera may be embedded in cavity 1210 at the distal tip of the catheter. Cavity 1210 may be integrally formed with the distal portion of the cavity and may have dimensions that match the length/width of the camera so that the camera does not move relative to the catheter. A camera may be adjacent to the working channel 1220 of the catheter to provide a near-field view of the tissue or organ. In some cases, the pose or orientation of the imaging device can be controlled by controlling rotational movement (eg, roll) of the catheter.

[0081] Power to the camera may be provided by a wired cable. Optionally, the cable wires may be located in a wire bundle that provides power to the cameras as well as lighting elements or other circuitry at the distal tip of the catheter. The camera and/or light source may be powered from a power source located in the handle portion via wires, copper wires, or via any other suitable means extending the length of the catheter. In some cases, real-time images or videos of tissues or organs may be wirelessly transmitted to an external user interface or display. Wireless communication may be WiFi, Bluetooth, RF communication, or other forms of communication. In some cases, the images or videos captured by the cameras may be broadcast to multiple devices or systems. Optionally, image and/or video data from the camera may be transmitted along the length of the catheter via wire, copper wire, or any other suitable means to a processor located within the handle portion. . Image or video data can be transmitted to external devices/systems via wireless communication components within the handle portion. In some cases, the system may be designed so that the wires are not visible or exposed to the operator.

[0082] In conventional endoscopy, illumination light may be provided by a fiber cable that transmits light from a light source located at the proximal end of the endoscope to the distal end of the robotic endoscope. In some embodiments of the present disclosure, small LED lights may be used and embedded in the distal portion of the catheter to reduce design complexity. Optionally, the distal portion may include structure 1230 having dimensions that match the dimensions of the miniature LED light source. As shown in the illustrated example, two cavities 1230 may be integrally formed with the catheter to receive two LED light sources. For example, the outer diameter of the distal tip can be about 4-4.4 millimeters (mm) and the diameter of the working channel of the catheter is about 2 mm so that two LED light sources can be embedded in the distal end. could be. The outer diameter can be any range less than 4 mm or greater than 4.4 mm, and the diameter of the working channel can be any range depending on the size of the tool or the particular application. Any number of light sources may be included. The internal structure of the distal portion can be designed to accommodate any number of light sources.

[0083] Optionally, each of the LEDs may be connected to a power wire that extends to the proximal handle. In some embodiments, the LEDs may be soldered to separate power wires that are later bundled to form a single strand. In some embodiments, the LED may be soldered to a pull wire that supplies power. In other embodiments, the LED can be crimped or connected directly to a pair of power wires. Optionally, a protective layer, such as a thin layer of biocompatible adhesive, can be applied to the front surface of the LED to provide protection while still allowing light emission. Optionally, an additional cover 1231 may be placed on the front end face of the distal tip to provide precise positioning of the LEDs and sufficient space for adhesive. Cover 1231 may be constructed of a transparent material that matches the refractive index of the adhesive so that illumination light is not blocked.

[0084] In some embodiments, one or more sensors may be embedded within the distal portion of the catheter. Sensors may be used in conventional robotic bronchoscopes to track tip position, and these sensors are typically located at the distal tip, thereby resulting in an enlarged tip. Provided steerable catheters may bundle one or more electronic components to provide a compact design. Optionally, the illumination source and one or more position sensors may be combined into a bundle. FIG. 13 shows an example of a compact configuration of electronic elements located in the distal portion. In some embodiments, a position sensor, such as an electromagnetic (EM) sensor, can be used to accurately track the position of the distal tip of the catheter. For example, an electromagnetic coil 1310 located at the distal end may be used to detect the position and orientation of the distal tip of the catheter during placement of the catheter within an anatomical system (eg, an anatomical lumen network). , can be used with an electromagnetic tracking system. Optionally, the coils are angled to provide sensitivity to electromagnetic fields along different axes, and the guided guidance system disclosed has the ability to measure six degrees of freedom (three positional degrees of freedom and three angular degrees of freedom). can give to

[0085] Optionally, one or more EM sensors 1310 may be located at the distal portion and may be arranged in a spatial configuration adjacent to or behind an illumination source 1320 (eg, an LED). Optionally, the EM sensor and LED light source may form bundle 1300 . The EM sensor's power cable can be bundled with the LED's wire, resulting in reduced space and reduced complexity. In some cases, spatial registration can provide differential 5D or fused 6D measurements that allow precise positioning and orientation sensing of the catheter distal tip. During the procedure, an electromagnetic field generator positioned next to, below, or above the patient's torso can locate the EM sensor and thereby track the position of the catheter tip in real time.

Construction and design of pull wires
[0086] The robotic bronchoscope may include one or more pull wires for controlling the articulation of the catheter. In conventional endoscopes, the distal ends or portions of one or more pullwires may be fixedly secured or attached to a control ring such that manipulation of the pullwires by the control unit causes the catheter to A force or tension that can steer or articulate (e.g., up, down, pitch, yaw, or any direction therebetween) a particular section or portion (e.g., the distal section) of the controlled You can join the ring. FIG. 14 shows an example of a conventional configuration of pull wires 1413 attached to a control ring structure 1411 and a novel configuration 1420 of the present disclosure. A control ring may be attached to the distal end of catheter 1415 . Typically, the pull wire tip is welded or soldered to the control ring 1411, which may also be attached to the distal tip by welding. Welding processes can be costly, cumbersome, and complicated. Moreover, if one pull wire breaks or malfunctions, the entire steering control function may be affected.

[0087] A provided robotic bronchoscope can include individually controlled pull wires, each of which is directly connected to a distal portion. As shown in example 1420, one or more pull wires 1423 may be attached to the integrally formed structure 1421 of the distal portion. For example, integrally formed structure 1421 can be a groove molded with the distal tip. The grooves may have dimensions or sizes that match the dimensions of the distal end 1421 of the pull wire so that the pull wire can be conveniently crimped at the distal end. This may advantageously improve assembly efficiency. In some examples, the pull wire may be rigidly secured to the groove in the distal end of the pull wire such that the distal end of the pull wire cannot move relative to the distal portion of the catheter.

[0088] The pull wire configuration may also provide increased reliability when manipulating the distal portion. For example, since each pull wire is individually connected to the distal portion and controlled individually, the articulation force can be dynamically adjusted in response to different pull wire configurations. For example, articulation forces can be recalculated and control signals for controlling pull wires can be dynamically adjusted based on available pull wires in the event a pull wire breaks.

[0089] The convenient assembly of the pull wires to the distal portion may also provide flexibility in designing the pull wire configuration. For example, the number or combination of pull wires can be dynamically selected or adjusted to meet different performance or design requirements. FIG. 15 shows various configurations of pull wires for robotic catheter systems. In some embodiments, the unitary structure (groove) for receiving the pull wire may be pre-machined. For example, four grooves can be integrally formed with the catheter, and one or more pull wires are fixedly connected/fixed to one or more grooves selected from the plurality of grooves to form different configurations 1510, 1530. can be crimped. As shown in the examples, any number of grooves/slots or any given subset of grooves/slots may be selected to receive or couple to a pull wire at one end. Optionally, once slot/groove combinations are selected to be coupled to corresponding pullwires, a pullwire configuration pattern may be formed, and the mapping relationship between the selected grooves/slots and pullwires is communicated to the control unit. can be sent. Control signals may then be generated during articulation based on the mapping relationship to achieve the desired articulation forces.

[0090] In another example, the pre-machined grooves can have various configurations. For example, the three pull wire configuration 1520 may have three grooves approximately 120° apart. In some cases, a virtual mapping algorithm may map a 3-wire configuration to a 4-wire configuration. The virtual mapping algorithm can also be used to update new mapping relationships if one or more pull wires malfunction/break during operation. Such a unitary design of the pull wire arrangement advantageously simplifies the assembly and manufacturing process while preserving the kinematic dynamic performance of the catheter.

Guidewire with inflatable tip
[0091] In some embodiments, a guidewire may be used during a bronchoscopic procedure. A guidewire is usually inserted well past the tip of the bronchoscope to enter the desired airway, and then the bronchoscope is slid over the guidewire to allow it to enter the selected passageway. obtain. Because the diameter of the guidewire is small compared to the diameter of the bronchoscope, the guidewire may not have sufficient stiffness and/or sufficient frictional force to secure the guidewire within the airway.

[0092] Guidewires of the present disclosure may have an expandable outer diameter feature at the distal end. FIG. 16 shows an example guidewire 1600 with an expandable tip. A guidewire 1601 may be threaded through the working channel of the catheter/bronchoscope to assist in navigating the airway in the lungs. Optionally, a guidewire can be extended beyond the tip of the catheter into the desired airway, and the catheter can then be slid over the guidewire to reach the desired location. The expandable tip can be implemented using various suitable methods. Additional components 1603, such as, for example, an expandable balloon, may be positioned at or near the distal end of the guidewire. The balloon may be connected through a working channel to a balloon inflation source or pump for inflation or deflation of the balloon.

[0093] Optionally, the guidewire may include perforations. The diameter of the deflated balloon may be equal to the diameter of the elongated arm (eg, bronchoscope catheter). Optionally, the deflated balloon may be slightly larger in diameter than the elongated arms. The guidewire may be capable of moving distally or proximally. The guidewire may be attached to an air pump for inflating and withdrawing air from the guidewire, which in turn inflates and deflates the balloon, respectively. The balloon may remain deflated during insertion of the guidewire into the airway. While reaching the proper location, the balloon is inflated by pumping air. Once the bronchoscope reaches the desired forward position, the balloon can be deflated by expulsion of air, which can allow the guidewire to move forward. In some embodiments, the expandable tip is folded using materials such as shape memory alloys (SMA), electroactive polymers (EAP), and ferrofluids, along with their corresponding expansion and contraction control mechanisms. It can be made with any possible mesh structure. The fixation element can have any other form to ensure firm fixation of the guidewire. For example, the fixation element may be a metal wire that is radially expandable or collapsible. The locking element may be actuated by a slide actuator that slides linearly to change the position of the locking element, in particular to unfold it or return it to its folded position. Sliding motion of the actuator may be translated into a change in the position (state) of the fixation element (e.g., the fixation element may deploy and expand radially to provide a structure that securely locks the guidewire in place). or vice versa, the fixation element is radially contracted back to its folded state.

[0094] FIG. 17 illustrates another example of a catheter tip design 1701. As shown in FIG. In the illustrated example, tip 1701 can have a diameter that is larger than the diameter of flexure section 1702 and/or shaft 1703 . Working channel 1708 may be deformable (eg, expandable/collapsible). Working channel 1708 may be formed of a resilient material (eg, plastic) that can accommodate instruments having variable dimensions. For example, larger instruments, such as biopsy instruments, therapeutic instruments, energy devices, etc., can cause the distal portion of the working channel to expand when passed through working channel 1708 .

[0095] In a first example 1710, the LED light source or light guide can be replaced after the endoscope reaches the target location. In a second example 1712, the LED light source 1711 can be embedded in the tip. In a third example 1713, the LED light source can be embedded in the tip while the light guide can be removable. The tip may include other electronic components, such as camera 1707, as described elsewhere herein. The endoscope can also include a handle portion 1704 similar to the handles described elsewhere herein. For example, the handle portion may include luers 1705 and electrical interfaces 1706 for various functions.

[0096] While preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, modifications, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be used in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims (28)

An articulating flexible endoscope comprising:
a distal tip portion steerable via a drive mechanism;
a bending section connected at a first end to the distal tip portion and connected to a shaft portion at a transition interface, the bending section being articulated by one or more pull wires;
and said shaft portion including one or more load transmission tubes for receiving said one or more pull wires thereby improving stability of said shaft portion. The flexible articulating endoscope of Claim 1, wherein the distal tip portion includes structure for receiving an imaging device, a position sensor, and an illumination device. The articulating flexible endoscope of claim 1, wherein each of the one or more pull wires is disposed within a respective load transfer tube lumen of the one or more load transfer tubes. . The flexible articulating endoscope of claim 1, wherein the bending section is bent in two or more directions by the one or more pull wires. The flexible articulating endoscope of claim 1, wherein the one or more load transfer tubes are rigidly secured to the transition interface and have a length greater than the length of the shaft portion. The articulating flexible endoscope according to claim 1, wherein the one or more load transfer tubes have a non-linear configuration. The articulating flexible endoscope according to claim 1, wherein the one or more load transfer tubes have a helical configuration. The flexible articulating endoscope of claim 1, wherein the shaft portion includes a tube with integrally formed structure for varying the stiffness of the shaft portion. An articulating flexible endoscope according to claim 1, further comprising a deformable working channel. Further comprising a handle portion for processing image data, for providing power to one or more electronic components located at the distal tip portion, or for communicating with an external device. 2. The flexible articulating endoscope of claim 1, including one or more components configured to establish a . The articulating flexible endoscope according to claim 10, wherein the handle portion includes an interface configured to couple the handle portion to an instrument drive mechanism. 12. The articulating flexible endoscope according to claim 11, wherein said interfaces are an electrical interface and a mechanical interface. 11. The flexible articulating endoscope of claim 10, wherein the handle portion includes a mechanical control module for interfacing with an irrigation system or an aspiration system. A disposable endoscope,
a distal tip portion including an imaging device, a position sensor, and an illumination device;
a bending section connected at a first end to the distal tip portion and at a second end to a shaft portion, the bending section being articulated by one or more pull wires; and,
and said shaft portion including one or more load transmission tubes for receiving said one or more pull wires thereby improving stability of said shaft portion. 15. A disposable endoscope according to claim 14, wherein the distal tip portion includes structure for receiving the imaging device, the position sensor and the illumination device. 15. The disposable endoscope of Claim 14, wherein the imaging device, the position sensor, and the illumination device are arranged in a compact configuration. 15. A disposable endoscope according to claim 14, wherein the one or more load transfer tubes have a length greater than the length of the shaft portion. 15. The disposable endoscope of claim 14, wherein each of the one or more pull wires is disposed within a respective load transfer tube lumen of the one or more load transfer tubes. 15. The disposable endoscope of Claim 14, wherein the one or more pull wires are movable with respect to the one or more load transfer tubes. 15. The disposable endoscope of Claim 14, wherein the bending section bends in more than one direction with the one or more pull wires. A disposable endoscope according to claim 14, wherein the one or more load transfer tubes have a non-linear configuration. 15. A disposable endoscope according to claim 14, wherein the one or more load transfer tubes have a helical configuration. 15. The disposable endoscope of Claim 14, wherein the shaft portion includes a tube with an integrally formed structure for varying the stiffness of the shaft portion. 15. The disposable endoscope of Claim 14, further comprising a deformable working channel. Further comprising a handle portion, the handle portion for processing image data, providing power to the imaging device, the position sensor and the lighting device, or establishing communication with an external device. 15. The disposable endoscope of claim 14, comprising one or more configured components. A disposable endoscope according to claim 25, wherein the handle portion includes an interface configured to couple the handle portion to an instrument drive mechanism. 27. A disposable endoscope according to claim 26, wherein said interface comprises an electrical interface and a mechanical interface. A disposable endoscope according to claim 27, wherein the mechanical interface is configured to removably couple the handle portion to the instrument drive mechanism.

Images